Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075559
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 1MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| BUTORPHANOL TARTRATE | BUTORPHANOL TARTRATE | 2MG/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/20/2000 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75559ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/13/2002 | SUPPL-4 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/13/2002 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/2001 | SUPPL-1 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |